Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
170 participants
OBSERVATIONAL
2010-01-31
2013-12-31
Brief Summary
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Detailed Description
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To assess aldosterone resistance at birth by a non invasive measurement of urinary aldosterone, in order to evaluate its intensity as a function of gestational age. Determination of normal values of urinary aldosterone concentration in each group.
Secondary objectives:
Comparison of plasma and urinary electrolytes concentrations with hormonal measurements and clinical parameters. Evolution of these biological parameters throughout the first year of life, depending on gestational age at birth.
Methodology : multicentric study, open study Two hundred-forty newborns will be included in order to constitute 4 groups of 60 children, classified according to their gestational age: \< 28 GW, 28 - \< 33 GW, 33- \< 37 GW, \> 37 GW.
Inclusion criteria: every newborn will be included, after written parental consent was obtained.
Study :
Urinary samples will be collected onto a gauze compress, during the first 24 hours of life, at day three, and at 1, 3, 6 and 12 months. A blood sample will be obtained from systematic umbilical cord blood collection at birth and during the Guthrie test at day three. Aldosterone and renin concentrations will be measured in BICETRE Hospital laboratory. Plasma and urinary electrolyte concentrations will be measured in the Biochemistry department. DNA samples will also be gathered from umbilical cord blood for future genetic investigations (functional polymorphisms of the MR gene).
Perspectives This study will permit to assess the intensity of aldosterone resistance in full-term and preterm newborns, by a non invasive method. It should bring new insights into the mechanisms of hormonal regulation of sodium balance in preterm newborns and during the first year of life. Urinary aldosterone assessments may open new perspectives for therapeutic management of water and sodium waste in premature infants.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Group "< 28"
• Gestational Age \< 28 weeks
No interventions assigned to this group
Group "28 - < 33"
• Gestational Age : 28 - \< 33 weeks
No interventions assigned to this group
Group "33- < 37"
Gestational Age : 33- \< 37 weeks
No interventions assigned to this group
Group "> 37"
Gestational Age \> 37 weeks
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Maternal age ≥ 18 and ≤ 45 years,
* Written parental consent
* Normal obstetrical ultrasounds
* Neonatal - Birth by vaginal delivery or cesarean section
Exclusion Criteria
* Type 1 or type 2 diabetes,
* Adrenal or hypophyseal deficiency
* Treatment for arterial hypertension
* Neonatal
* Perinatal anoxia (defined by an Apgar score \< 5 at 5 min and pH \< 7,10 and lactacidemia \> 9 mmol/l at blood cord).
* Congenital malformation
* Chromosomic abnormalities
24 Weeks
41 Weeks
ALL
No
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Pascal BOILEAU, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Assistance Publique- Hôpitaux de Paris: Antoine Beclere Hospital
Clamart, Île-de-France Region, France
Countries
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References
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Martinerie L, Viengchareun S, Delezoide AL, Jaubert F, Sinico M, Prevot S, Boileau P, Meduri G, Lombes M. Low renal mineralocorticoid receptor expression at birth contributes to partial aldosterone resistance in neonates. Endocrinology. 2009 Sep;150(9):4414-24. doi: 10.1210/en.2008-1498. Epub 2009 May 28.
Martinerie L, Pussard E, Yousef N, Cosson C, Lema I, Husseini K, Mur S, Lombes M, Boileau P. Aldosterone-Signaling Defect Exacerbates Sodium Wasting in Very Preterm Neonates: The Premaldo Study. J Clin Endocrinol Metab. 2015 Nov;100(11):4074-81. doi: 10.1210/jc.2015-2272. Epub 2015 Sep 8.
Other Identifiers
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B91017-20
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
P081211
Identifier Type: -
Identifier Source: org_study_id